Optimization of Golimumab Treatment in Ulcerative Colitis

H

Hospital de Manises

Status and phase

Unknown
Phase 4

Conditions

Colitis, Ulcerative

Treatments

Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
Drug: Golimumab treatment optimization.

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03669029
JHV-GOL-2018-01

Details and patient eligibility

About

This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

Exclusion criteria

  • Patients with Crohn's disease or colitis pending classification
  • Patients with ileoanal pouch
  • Patients with perianal fistulas related to the disease
  • Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
  • Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
  • Patients with moderate or severe heart failure (NYHA grade III / IV)

Trial design

50 participants in 2 patient groups

Week 6 Responders
Experimental group
Description:
In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
Treatment:
Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
Week 6 Non Responders
Experimental group
Description:
In patients without clinical response at week 6, golimumab treatment will be optimized.
Treatment:
Drug: Golimumab treatment optimization.

Trial contacts and locations

0

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Central trial contact

Joaquín Hinojosa del Val, MD; Vanesa Carretero López

Data sourced from clinicaltrials.gov

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